(254 days)
All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion.
Novation Element press-fit femoral stems with HA coating are intended for press-fit fixation.
The Novation Element Press-Fit Femoral Stem is manufactured from Ti-6Al-4V with a grit blast surface and HA coating. The stem has a 12/14 taper. The Novation Element Press-Fit Femoral stem is available in a standard and high neck offset configurations, and collared and collarless configurations. The stem has a trapezoidal cross-sectional stem geometry with a distal taper, and it contains vertical and horizontal grooves along its bone contacting surfaces.
The Novation Element Press-Fit Femoral Stems are intended for press-fit applications and are not intended for use with bone cement.
This document is a 510(k) premarket notification decision letter from the FDA for the Exactech Novation Element Press-Fit Femoral Stem. It does NOT contain information about acceptance criteria, device performance tables, sample sizes, expert qualifications, or study methodologies typically found in a clinical study report or a different section of a 510(k) submission that might detail validation testing.
The document states:
"The only modification to the proposed Exactech Novation Element Press-Fit Femoral Stems is the vendor applying the HA coating. No other changes were made to the proposed device. HA coating characterization, distal fatigue testing, and range of motion analysis were performed to demonstrate that the proposed Exactech Novation Element Press-Fit Femoral Stems are substantially equivalent to the identified predicate devices."
This indicates that non-clinical testing was performed for HA coating characterization, distal fatigue testing, and range of motion analysis. However, the details of these tests, including specific acceptance criteria, reported performance values, sample sizes, or ground truth establishment are not provided in this document.
Therefore, I cannot provide the requested information based on the provided text. This document is a regulatory approval letter, not a detailed technical report of the device's performance study.
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.